Events

Recall of ENVOY 500 AST Reagent Kit, reference 55255

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ELITech Clinical Systems SAS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69024
  • Event Risk Class
    Class 3
  • Event Number
    Z-0006-2015
  • Event Initiated Date
    2014-08-11
  • Event Date Posted
    2014-10-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129364
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Nadh oxidation/nad reduction, ast/sgot - Product Code CIT
  • Reason
    Some users of envoy 500 ast reagent kit, reference 55255, for envoy 500 systems are observing that quality control (qc) fails before the product expiry is reached.
  • Action
    ELITech sent an Urgent Product Recall Notice letter dated August 12, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To All Users, ***Effective immediately, please discontinue using this product.*** Actions to be taken: "Laboratories must not use this product and must destroy all remaining inventory of the product. "If you have transferred any of this product to another location, please forward a copy of this bulletin to that location. "All users receive ENVOY 500 AST REAGENT KIT, reference 55255, from distributors. To be certain everyone who is possibly affected by this is contacted, we are sending this communication to all registered users. As confirmation of receipt of this notice, please return the attached confirmation receipt to Technical Support by fax (401-642-9003) within 48 hours of receipt. On August 20, 2014:, customers were contacted with an interim solution. On September 3, 2014, the firm sent Technical Bulletin 5056 and Distributor Notice D057/Customer Notice C061 to all Envoy users notifying that the recalled Envoy AST Reagent (ref 55255) was being discontinued; the old Envoy AST Reagent (ref. 55250) was being reinstated. On September 23, 2014, the firm sent the URGENT: PRODUCT RECALL NOTICE "UPDATE", dated 19 September 2014, to all Envoy users stating that old (original) Envoy 500 AST Reagent Kit (ref 55250) will replace the recalled Envoy 500 AST Reagent Kit (ref 55255). As confirmation of receipt of this notice, please return the attached confirmation receipt to Technical Support by fax (401-642-9003) within 48 hours of receipt. Customers with questions about this recall, please call the Technical Support at 1-855-354-8324 (1-855-ELITECH).

Device

ENVOY 500 AST Reagent Kit, reference 55255
  • Model / Serial
    Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015;
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. || Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. || Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
  • Manufacturer
    ELITech Clinical Systems SAS

Manufacturer

ELITech Clinical Systems SAS
  • Manufacturer Address
    ELITech Clinical Systems SAS, Zone lndustrielle, SEES France
  • Source
    USFDA